1. Field of the Invention
The present invention relates to the manufacture of pharmaceutical and pharmaceutical-like product. More particularly, the present invention relates to an apparatus and process for manufacturing pharmaceutical and pharmaceutical-like product.
2. Description of Related Art
Contemporary quality control methods for pharmaceutical and pharmaceutical-like product involve the use of batch-sampling techniques. The batch-sampling techniques test samples from batches of the product, such as through the use of wet chemistry, after the product has been made. Contemporary batch sampling techniques use frequent and sometimes random batch sampling for various characteristics of the final product, such as, for example, quality, concentration and homogeneity. However, these batch-sampling techniques suffer from drawbacks because of their inefficiency and inaccuracy.
Batch-sampling assumes that all of the product attributes in a particular batch are normally distributed and have the same or very similar characteristics as the sampled product from the batch. Where the chosen samples do not meet the required tolerances, an entire batch can be discarded or re-processed for additional sampling and testing. If the chosen unacceptable samples do not have the same characteristics as other acceptable product in the batch, then acceptable product may be discarded along with the rejected samples or at least need to undergo more costly testing. Batch-sampling can be particularly inaccurate where the error or flaw in the process is random, non-repeating or of a non-linear nature. Such flaws or errors in the manufacturing process may provide for only a fraction of the product of the batch being unacceptable but result in an entire batch being discarded or re-tested, as a result of the use of batch sampling.
Another significant drawback of batch-sampling techniques is where the chosen samples meet the required tolerances, but where a fraction of the batch is actually unacceptable and not representative of the tested sample. In such a situation, unacceptable product may be provided to the consumer because of the inherent flaw in the quality control method.
An additional drawback in batch-sampling techniques is that the testing is done at the end of the process and provides little, if any, information for corrective action to be taken with regard to the manufacturing process and its various steps. The batch-sampling technique can provide overall information for sampled product, but does not indicate at which point or which particular step in the process that a flaw is occurring, such as, for example, inadequate dosing or detrimental heating.
Another drawback of batch-sampling technique is that it is done off-line of the manufacturing process, which adds time to the overall manufacturing process, and can also be labor intensive. The cost in time and labor is increased where more stringent standards are applied to a particular product so the batch-sampling technique utilizes a higher portion of samples for testing.
Contemporary tablet manufacturing methods use wet granulation and direct compression approaches to add the active ingredient into the tablet ingredients. After mixing to achieve homogeneity, tablets are produced, which are each intended to have the required dosage of active ingredient. These types of contemporary batch manufacturing techniques suffer from drawbacks due to their inefficiency and inaccuracy.
Contemporary batch production attempts to homogeneously mix and equally distribute the active ingredient to each of the tablets in the batch. When the active ingredient in the batch is not equally distributed, such as, for example, an unacceptable concentration, the non-homogeneity of the active ingredient will be distributed throughout the entire batch rendering all of the tablets unacceptable. Additionally, inadequate mixing in other ingredients will be distributed throughout the entire batch rather than just to individual tablets.
Contemporary machines that manufacture pharmaceutical product suffer from the drawback of having a large footprint. These machines may be broken into a number of different units that handle different steps of the process. The use of separate units adds labor and time to the process, such as, for example, requiring the product to be moved between different machines.
In addition, the pharmaceutical product is usually stored for days awaiting availability of process machinery for the next manufacturing step. This delay increases production time and increases manufacturing costs.
Contemporary machines and techniques also require a longer time and added labor to change-over to different products, if the machine is capable of doing so at all. To produce a different pharmaceutical product, these contemporary machines require thorough cleaning of the components to avoid contamination of the next batch from the previous production ingredients.
Accordingly, there is a need for an apparatus and process for manufacturing pharmaceutical and pharmaceutical-like products that reduce or eliminate these manufacturing and quality control drawbacks of the contemporary devices and techniques.